REF-EN 01698 INTERCEPT Blood System for Plasma, Processing Set for Plasma : Mislabelling in the Instructions for Use and product labels

 

Affected Medical Device : 

Intercept Blood System for Plasma

Processing Set for Plasma

 

MDA Reference Number : MDA/FCA/2021-P100

 

MDA Registration Number : GD93201723918

 

Decription : In 2015, Cerus and the contract manufacturer of the INTERCEPT Plasma processing set jointly initiated a project to remove DEHP-containing components from the processing set. After completion of the project, product labels and Instructions for Use (IFU) were updated to remove the DEHP symbol or text and residual risk statement. In April 2021, it was discovered that two of the components, breakaway cannulae and Y-junction connectors, do contain DEHP.

 

Local Establishment Contact Detail :

Janice Lim Siew Chen
Regulatory Affairs Executive
United Italian Trading (M) Sdn Bhd
25th Floor, PJX No.16A, Persiaran Barat, 46050 Petaling Jaya, Selangor
03-79653012

Email : janice.lim@uitm.net

 

 A copy of FSN.